DSUVIA is indicated for the management of acute pain,severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults. DSUVIA is for use in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments.
Please see Limitations of Use and BOXED WARNING under Important Safety Information below.
DSUVIA showed an average of 3 hours between doses over a 12-hour period, with a minimum redosing interval of 1 hour.2*†
DSUVIA showed a greater pain intensity difference to baseline vs placebo (P=0.002) at 15 minutes, the first assessment.2*
DSUVIA comes in one strength and avoids calculations that can complicate dosing and lead to errors.1,3
DSUVIA is administered sublingually with a single-dose applicator, and can be given after an IV line is removed.1
Sublingual delivery may circumvent the risks associated with IV lines, such as infiltration and phlebitis.1,4
The prefilled applicator delivers one tablet of DSUVIA, so there’s no leftover drug to waste and witness after administration.1,5
*The efficacy and safety of DSUVIA were demonstrated in a pivotal trial of 161 post-operative abdominal surgery patients. The primary endpoint was time-weighted summed pain intensity difference to baseline over 12 hours (SPID12). A secondary endpoint was pain intensity difference to baseline at each evaluation time point. Redosing interval (time between doses) was also recorded.1,2
†Patients may require more frequent redosing (minimum interval 1 hour) than the 3-hour average when initiating DSUVIA.1
DSUVIA offers a sublingual option when opioids are needed in a medically supervised setting. The prefilled single-dose applicator delivers one 30-mcg tablet under the tongue, with a minimum of 1 hour between doses.1
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Patient has acute pain and requiresfrequent redosing
Inguinal hernia repair
Patient has acute pain and no immediateIV access
Patient has acute pain and moderaterenal impairment
Patient has acute pain and IV hasbeen removed
Patient has acute pain and requires frequent redosing
Patient receives dose of IV fentanyl post-operatively. After 30 minutes, during transition from phase 1 to phase 2 care, her pain increases as analgesia wears off, and she requires another dose.
for a minimum of 1 hour between doses1
Patient has acute pain and no immediate IV access
IV infiltrates en route from surgery to recovery. Patient's pain is rapidly increasing. Physician orders insertion of new IV, and patient waits for recannulation.
for sublingual delivery
Patient has acute pain and moderate renal impairment
Patient receives IV morphine post-operatively. Drug clearance is reduced due to renal insufficiency. Patient becomes too sedated for discharge and is admitted to the hospital.
for a single fixed dosage1
Patient has acute pain and IV has been removed
Patient receives IV fentanyl following surgery. IV is then removed in anticipation of discharge. Now patient is complaining of worsening pain and wants IV put back in place.
for a non-IV option
Learn about the single-
strength dosing and
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.
DSUVIA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DSUVIA, and monitor all patients regularly for the development of these behaviors or conditions.
The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or inducer.
DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The most commonly reported adverse reactions (≥ 2% and higher than placebo) were nausea, headache, vomiting, dizziness, and hypotension.
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the AcelRx Medical Information Contact Center at 1-855-925-8476 or AcelRxMedInfo@rmpdc.org.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.